Quality Assurance Operations Specialist – Biopharma

Novartis Farmacéutica; Carlsbad (CA); On-site; USD 59,000 - 110,000; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) with company contribution and 2

Generous time off

Job summary

Novartis near Carlsbad is seeking a QA Operations Specialist to support manufacturing, QC, and supply chain with rigorous GxP compliance. You will review batch release records, SOPs, CAPAs, deviations, and change controls while guiding cross-functional teams on quality decisions.

The role emphasizes live batch record review, regulatory inspection readiness, and ongoing cGMP adherence, with a focus on continuous quality improvement and training across sites.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, or a related field.
• Minimum 3 years of GxP biopharmaceutical or API manufacturing operations.
• Minimum 2 years in a Quality Assurance role within a regulated environment.
• Quality Assurance or Quality Control experience in pharmaceutical environments with environmental monitoring and cleanliness zones.
• Experience reviewing quality documentation and supporting compliance within manufacturing operations.
• Experience supporting regulatory inspections, continuous improvement initiatives, or operational excellence projects.
• Proven ability to collaborate effectively across functions and build strong working relationships.

Responsibilities

• Provide Quality Assurance support for manufacturing, quality control, engineering, and supply chain operations.
• Review and approve test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls.
• Perform shop floor oversight and provide compliance guidance supporting operational decision-making.
• Conduct live batch record review and execute acceptable quality limit inspections.
• Support continuous quality improvement initiatives that enhance manufacturing quality, compliance, and operational efficiency.
• Support regulatory inspection readiness, execute inspection activities, and maintain ongoing site cGMP compliance.
• Deliver quality training and collaborate across teams to strengthen quality culture and performance.

Skills

GxP experience

QA collaboration

Quality documentation

Regulatory inspection support

Education

Bachelor's degree in Life Sciences

Job description

Novartis near Carlsbad is seeking a QA Operations Specialist to support manufacturing, QC, and supply chain with rigorous GxP compliance. You will review batch release records, SOPs, CAPAs, deviations, and change controls while guiding cross-functional teams on quality decisions.

The role emphasizes live batch record review, regulatory inspection readiness, and ongoing cGMP adherence, with a focus on continuous quality improvement and training across sites.